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510(k) Data Aggregation

    K Number
    K120247
    Device Name
    EASYDEX
    Manufacturer
    VINELAND SYRUP INC.
    Date Cleared
    2012-06-21

    (146 days)

    Product Code
    MRV
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    VINELAND SYRUP INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EasyDeX is a flavored non-carbonated beverage containing specific quantities of dextrose (D-glucose). The manufactured beverages contain three (3) different quantities of glucose; 50, 75, and 100 grams quantities per 10 oz. bottle. This product is used in the administration of an in Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and other related disease conditions. This product is for oral consumption only.
    Device Description
    EasyDeX is a water-based flavored beverage containing specific quantities of dextrose (d-glucose). The product is manufactured in two (2) flavors (Fruit Punch and Orange) and three (3) concentrations.
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